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Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin

Primary Purpose

Polycystic Ovary Syndrome, Insulin Resistance

Status

Withdrawn

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Metformin

Clomiphene citrate

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women aged from 18 to 35
Infertility for a period of a year or more or 6 month of irregular menstrual cycle
PCOS under the Rotterdam criteria
Insulin resistance HOMA-IR > 2.5
Normal semen analysis values
Normal values of the following blood analysis: FSH, LH, Estradiol, AMH, TSH, Prolactine, Fasting glucose level, hemoglobin A1C, AST, ALT, alkaline phosphatase, SHBG, 17OH progesterone, DHEAS, Androstenedione, total testosterone, LDL, HDL, total cholesterol, Triglycerides, oral glucose tolerance test

Exclusion Criteria:

Tubular factor
Normal ovarian reserve
Prior use of CC or Metformin, hypoglycemic agents, glucocorticoids, anti-androgen, weight-loss agent or oral contraceptives in the past 6 months
Neoplasia
BMI > 35
Renal, hepatic or cardiac failure
Lactic, acidosis antecedent

Sites / Locations

Clinique Ovo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Metformin

Clomiphene Citrate

Arm Description

Outcomes

Primary Outcome Measures

Biochemical pregnancy

Rate of biochemical pregnancy

Secondary Outcome Measures

Ovulation rate

Live birth rate

Spontaneous abortion rate

BMI and waist size changing

Insulin resistance changing

AMH correlation/variation in function of Metformin

Full Information

NCT ID

NCT01638988

First Posted

July 9, 2012

Last Updated

July 24, 2015

Sponsor

Clinique Ovo

1. Study Identification

Unique Protocol Identification Number

NCT01638988

Brief Title

Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin

Official Title

Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome (PCOS) and a Resistance to Insulin. Randomised Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Previous studies have been done regarding same condition

Study Start Date

September 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinique Ovo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The results of studies conducted until now does not determine what the best way to treat infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study objective is to determine the best treatment for such patients. The long-term consequence health of women with PCOS are multiple. The woman with PCOS has a risk of developing metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin resistance plays an important role in all this medical condition. Clomiphene Citrate (CC) remains the first line treatment to induce ovulation in women with PCOS and anovulatory infertility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Insulin Resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Experimental

Arm Title

Clomiphene Citrate

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

cycle 2000 mg of Metformin : Day 1 to day 30; beginning with 1/2 tablet by day with an increasing until 4 pills by day to 6 cycle 2000 mg of Metformin : Day 1 ot day 30; 4 pills of Metformin by day Positive pregnancy test : 4 pills of Metformin by day until 12 weeks of pregnancy

Intervention Type

Drug

Intervention Name(s)

Clomiphene citrate

Intervention Description

Cycle 1: Day 3 to day 7; 50 mg; 1 tablet of Clomiphene Citrate by day Cycle 2: Day 3 to day 7; 100 mg; 1 tablet of Clomiphene Citrate two times a day Cycle 3 to 6 : Day 3 to day 7; 150 mg; 1 tablet of Clomiphene Citrate 3 times a day

Primary Outcome Measure Information:

Title

Biochemical pregnancy

Description

Rate of biochemical pregnancy

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Ovulation rate

Description

Ovulation rate

Time Frame

1 month

Title

Live birth rate

Time Frame

6 months

Title

Spontaneous abortion rate

Time Frame

6 months

Title

BMI and waist size changing

Time Frame

6 months

Title

Insulin resistance changing

Time Frame

6 months

Title

AMH correlation/variation in function of Metformin

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women aged from 18 to 35 Infertility for a period of a year or more or 6 month of irregular menstrual cycle PCOS under the Rotterdam criteria Insulin resistance HOMA-IR > 2.5 Normal semen analysis values Normal values of the following blood analysis: FSH, LH, Estradiol, AMH, TSH, Prolactine, Fasting glucose level, hemoglobin A1C, AST, ALT, alkaline phosphatase, SHBG, 17OH progesterone, DHEAS, Androstenedione, total testosterone, LDL, HDL, total cholesterol, Triglycerides, oral glucose tolerance test Exclusion Criteria: Tubular factor Normal ovarian reserve Prior use of CC or Metformin, hypoglycemic agents, glucocorticoids, anti-androgen, weight-loss agent or oral contraceptives in the past 6 months Neoplasia BMI > 35 Renal, hepatic or cardiac failure Lactic, acidosis antecedent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques Kadoch, Dr

Organizational Affiliation

Clinique Ovo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique Ovo

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H4P 2S4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin

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